Ignite Creation Date:
2024-05-06 @ 7:13 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02497287
Status:
COMPLETED
Last Update Posted:
2020-05-06
First Post:
2015-05-18
Brief Title:
A Long-term Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
An Open-label Long-term Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUSTAIN-2
Brief Summary:
The purpose of this open-label multicenter study is to assess the long term safety and efficacy of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression TRD
Detailed Description:
This is an open-label the researchers and participants know the treatment the participant is receiving multicenter more than 1 study site long-term safety and efficacy study of intranasal esketamine plus an oral antidepressant in participants with treatment-resistant depression TRD Participants will enter the study either directly direct-entry participants or after completing the Double-Blind Induction Phase of ESKETINTRD3005 transferred-entry participants The study consists of 4 phases Screening Phase 4 weeks Open-Label Induction Phase 4 weeks Open-Label OptimizationMaintenance phase 48 weeks and Follow up Phase 4 weeks Transferred entry non-responders in the ESKETINTRD3005 may enter study at the Open-Label Induction Phase and responders in the ESKETINTRD3005 may enter OptimizationMaintenance phase In the Open-Label Induction Phase participants will self-administer flexibly-dosed intranasal esketamine participants who are less than 65 years old self-administer 56 mg or 84 mg dose participants who are greater than or equal to 65 years old self-administer 28 mg 56 mg or 84 mg dose twice weekly for 4 weeks The starting dose for all participants 65 years old will be 28 mg In addition each direct-entry participants will be assigned to receive 1 of 4 selected oral antidepressant medications escitalopram or sertraline or duloxetine or venlafaxine extended release XR initiated on Day 1 of the open-label induction phase and continued through the duration of the study Transferred-entry participants will continue their same antidepressant from ESKETINTRD3005 through the duration of this study Participants who are responders at the end of the Open-Label Induction phase and transferred-entry responder participants from study ESKETINTRD3005 will enter the OptimizationMaintenance Phase where intranasal esketamine treatment sessions will be reduced from that in the induction phase twice weekly to weekly for the first 4 weeks of this phase and then individualized to either once weekly or once every other week based on the severity of depressive symptoms Participants safety and depressive symptoms will be assessed and monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004587-38 | EUDRACT_NUMBER | Janssen Research Development LLC | None |
| ESKETINTRD3004 | OTHER | None | None |